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FDA 510(k)

Megaloop Button System

K-Number: K232941 · 2024-05-03

ApplicantSuzhou Endophix Co., Ltd.
Decision Date2024-05-03
Product CodeMBI
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Megaloop Button System is a medical device manufactured by Suzhou Endophix Co., Ltd.. It received FDA 510(k) clearance on 2024-05-03 under approval number K232941. The device is classified under product code MBI. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Megaloop Button System?

Megaloop Button System is a medical device that received FDA 510(k) clearance on 2024-05-03. It is manufactured by Suzhou Endophix Co., Ltd.. The 510(k) number is K232941.

When was Megaloop Button System approved by the FDA?

Megaloop Button System received FDA 510(k) clearance on 2024-05-03, under approval number K232941.

What company makes Megaloop Button System?

Megaloop Button System is manufactured by Suzhou Endophix Co., Ltd..

What is the FDA product code for Megaloop Button System?

The FDA product code for Megaloop Button System is MBI.

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Other Devices by Suzhou Endophix Co., Ltd.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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